| CTRI Number |
CTRI/2024/05/067944 [Registered on: 27/05/2024] Trial Registered Prospectively |
| Last Modified On: |
25/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Effect of Awareness on Menstrual Hygiene Knowledge and Practice] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to find the efficacy of Awareness done in adolescent girls of school on topic Menstrual Hygiene Knowledge and Practice |
|
Scientific Title of Study
|
Effect of School Based Awareness on Menstrual Hygiene Knowledge and Practice among Adolescent Girls |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrNandiniM |
| Designation |
PG Scholar,Department of Swasthavritta |
| Affiliation |
Government Ayurveda Medical College and Hospital |
| Address |
Government Ayurveda Medical College and Hospital, Pulimoodu junction,Thiruvananthapuram
Thiruvananthapuram KERALA 695001 India |
| Phone |
8289838187 |
| Fax |
|
| Email |
nandini16051994@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DrNandiniM |
| Designation |
PG Scholar,Department of Swasthavritta |
| Affiliation |
Government Ayurveda Medical College and Hospital |
| Address |
Government Ayurveda Medical College and Hospital, Pulimoodu junction,Thiruvananthapuram
Thiruvananthapuram KERALA 695001 India |
| Phone |
8289838187 |
| Fax |
|
| Email |
nandini16051994@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DrSheelaS |
| Designation |
Professor and HOD,Department of Swasthavritta |
| Affiliation |
Government Ayurveda Medical College and Hospital |
| Address |
Government Ayurveda Medical College and Hospital, Pulimoodu junction,Thiruvananthapuram
Thiruvananthapuram KERALA 695001 India |
| Phone |
9847706888 |
| Fax |
|
| Email |
drsheelas@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda Medical College and Hospital,Pulimoodu Junction,Thiruvananthapuram-695001,Kerala,India |
|
|
Primary Sponsor
|
| Name |
NandiniM |
| Address |
PG Scholar,Government Ayurveda Medical College and Hospital,Pulimoodu Junction,Thiruvananthapuram-695001 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrNandiniM |
Government Ayurveda Medical College and Hospital,Pulimoodu Junction,Trivandrum |
Department of Swasthavritta,OP no:2,Government Ayurveda Medical College and Hospital,Thriuvananthapuram-695001 Thiruvananthapuram KERALA |
8289838187
nandini16051994@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) Government Ayurveda College Thiruvananthapuram |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Participants who has attained menarche |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:Awareness on Menstrual Hygiene Knowledge and Practice among adolescent girls for consecutive 3 months, Pathya/Apathya:, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Female |
| Details |
Adolescent girls of age group 12-17 years who has attained menarche selected after getting written informed consent from parents |
|
| ExclusionCriteria |
| Details |
Adolescent girls who are mentally challenged
Schools in which Awareness on Menstrual Hygiene Knowledge and Practice has been given on the same academic year in which study is going to be conducted |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of Awareness |
0th day,90th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
NIl |
|
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="3" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Menstruation is an essential phenomenon in an adolescent girl’s life and it is a complex biological phenomenon governed by the interplay of hormones, particularly estrogen and progesterone, which prepare the uterine lining for potential pregnancy.According to the WHO/UNICEF Joint Monitoring Programme 2012, menstrual hygiene management is defined as: “Women and adolescent girls are using a clean menstrual management material to absorb or collect menstrual blood, that can be changed in privacy as often as necessary, using soap and water for washing the body as required, and having access to safe and convenient facilities to dispose of used menstrual management materials. They understand the basic facts linked to the menstrual cycle and how to manage it with dignity and without discomfort or fear.†90 samples will be selected as per inclusion and exclusion criteria by simple random sampling from selected Government schools in urban region of Thiruvananthapuram district of Kerala state. Before taking survey, authority consent will be taken from school authority for conducting the study. Then informed consent will be obtained from the parents of the participants and assent from participants who are selected by simple random sampling. The data will be collected as pre-survey procedure through direct interview schedule with the help of a pre-validated structured questionnaire.[16]. The participant will be assured about the confidentiality of any kind of data obtained through the survey. After collecting data ,an Awareness class on Menstrual Hygiene Knowledge and Practice will be given to the participants which deals the areas like basics of menstruation with physiology, physical and psychological changes during menstruation, personal hygiene and its importance,nutritional status during menstruation, menstruation material to be used and its cleaning and changing time, problems associated with menstruation and mode of utilisation of ayurvedic measure for solving the issues etc to the participants; which will be given as 3 sessions during 3 consecutive menstrual cycle of the participants. Later the same questionnaire will be given to the participant for taking post-survey after first menstrual cycle following the Awareness class. Taking post-survey result ,analysis of pre-survey and post-survey result will be done to analyse the effectiveness of Awareness on Menstrual Hygiene Knowledge Practice among the participants. |